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NCT06363383Recruiting

A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants

A Double-blind Placebo-controlled Phase 1 Study to Evaluate the Safety and Efficacy of MB-001 in Single and Multiple Ascending Doses in Healthy Human Participants
Mage BiologicsPhase 1ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
MB-001
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Mage Biologics
Location
Adelaide, Australia
Timeline & enrollment
Phase
Phase 1
Start date
May 09, 2024
End date
May 01, 2025
Enrollment
48 participants
Primary outcome

Incidence and severity of adverse events (AEs),Clinically significant changes from baseline in vital signs,Clinically significant changes from baseline in physical examination findings,Clinically significant changes from baseline in clinical laboratory assessments,Clinically significant changes from baseline in ECG parameters

Summary

The goal of this clinical trial is to learn if the oral biologic MB-001 is safe in healthy
 volunteers. The main questions it aims to answer are:
 
 Is the drug safe when administered orally at increasing doses? Researchers will compare the
 drug with placebo to see if there are more side effects in those receiving the drug.
 
 Participants will receive a single or five daily doses of the drug or placebo and will be
 asked to stay in the clinic for five days following the last dose.

ICD-10 classifications
Ulcerative colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06363383
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06363383 through Pure Global AI's free database. This Phase 1 trial is sponsored by Mage Biologics and is currently Recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.